YY/T 0793.1-2022 Active

This document specifies the terms and definitions, requirements, test methods, and marking for water treatment equipment used in hemodialysis and related treatments.
This document applies to devices that process domestic drinking water for use in hemodialysis and related treatments, including:
a) Preparing concentrated solutions from powders or other highly concentrated media in dialysis facilities;
b) Preparing dialysis solutions, including dialysis solutions that can be used to prepare replacement solutions;
c) Re-processing dialyzers intended for multiple use after a single use;
d) Re-processing dialyzers not explicitly marked as intended for single use.
This document applies to all devices, pipelines, and fittings between the delivery point of domestic drinking water into the water treatment system and the point of use of dialysis water, such as water purification devices, online water quality monitors (e.g., conductivity monitors), and pipeline systems for distributing dialysis water.
This document does not apply to: - Dialysis solution supply systems (proportionally distributing water and concentrated solutions to prepare dialysis solutions); - Adsorber dialysis solution regeneration systems (regenerating and recirculating a small amount of dialysis solution and dialysis concentrate); - Hemodialysis filtration systems; - Blood filtration systems; - Systems for processing dialyzers intended for multiple use; - Peritoneal dialysis systems. Some of these devices, such as dialysis solution distribution systems and concentrate solutions, are described in other documents, such as YY 0598 and YY/T 0793.4.
This document also does not apply to the continuous monitoring of water purity used in the preparation of dialysis solutions, concentrated solutions, or for dialyzer re-processing as described in ISO 23500-1.